FDA Adverse Event
Injury
Summary report: N
AMISTEM H, HA COATED STEM SIZE 3 STD
MDR report key: 6349049
·
Received February 22, 2017
Report
- Report Number
- 3005180920-2017-00055
- Event Type
- Injury
- Date Received
- February 22, 2017
- Date of Event
- January 23, 2017
- Report Date
- March 31, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 20 FEBRUARY 2017. LOT 163094: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
A PERI-PROSTHETIC FRACTURE OF THE FEMUR OCCURED AS A RESULT OF THE PATIENT SLIPPING AND FALLING WHILST STILL IN HOSPITAL FOLLOWING THE PRIMARY HIP ARTHROPLASTY SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130990 | AMISTEM H, HA COATED STEM SIZE 3 STD | CEMENTESS FEMORAL STEM | LZO | MEDACTA INTERNATIONAL SA | 163094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |